Abstract: A laminate useful as a component of a medical implant, for example, useful as a component of an inflatable tissue expander. The laminate includes a base layer, an intermediate layer, and a top layer. When used as a component of a tissue expander, the laminate enables an internal chamber pressure of about 2.5 psi with an expander exterior compressive force of about 40 lbs.

Abstract: A prosthesis can include a shell and a needle guard coupled to a posterior portion of the shell. The shell can include a laminate having a base layer, a top layer, and a soft silicone gel intermediate layer disposed between the base layer and the top layer and of sufficient thickness for self-sealing of a needle hole therethrough. The needle guard can include a plurality of offset layers of offset, puncture-resistance structures that, in an expanded state, (i) collectively form a concave shape and (ii) provide a concave exterior surface along the posterior portion of the prosthesis for approximating a human anatomical feature. The needle guard can have a shape memory characteristic for urging the prosthesis toward the expanded state.

Abstract: A laminate useful as a component of a medical implant, for example, useful as a component of an inflatable tissue expander. The laminate includes a base layer, an intermediate layer, and a top layer. When used as a component of a tissue expander, the laminate enables an internal chamber pressure of about 2.5 psi with an expander exterior compressive force of about 40 lbs.

Abstract: A laminate useful as a component of a medical implant, for example, useful as a component of an inflatable tissue expander. The laminate includes a base layer, an intermediate layer, and a top layer. When used as a component of a tissue expander, the laminate enables an internal chamber pressure of about 2.5 psi with an expander exterior compressive force of about 40 lbs.

Abstract: Method for sterilizing a hydrogel composition include subjecting the composition to pulsed light comprising broadband spectrum radiation, the pulsed light being at a dose effective to sterilize the composition without causing significant change in rheology of the composition.

Abstract: Method for sterilizing a hydrogel composition include subjecting the composition to pulsed light comprising broadband spectrum radiation, the pulsed light being at a dose effective to sterilize the composition without causing significant change in rheology of the composition.

Abstract: A laminate useful as a component of a medical implant, for example, useful as a component of an inflatable tissue expander. The laminate includes a base layer, an intermediate layer, and a top layer. When used as a component of a tissue expander, the laminate enables an internal chamber pressure of about 2.5 psi with an expander exterior compressive force of about 40 lbs.

Abstract: An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion.

Abstract: A tissue expander includes an elastomeric shell having an anterior inside surface and a posterior inside surface with a self-healing layer abutting only a portion of the anterior inside surface. The layer is spaced apart from the posterior inside surface while facilitating folding of the shell prior to insertion into a tissue pocket and also enabling inflation of the shell subsequent to insertion by a fluid injected between the self healing layer and posterior surface.

Abstract: An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion.

Abstract: Method for sterilizing a hydrogel composition include subjecting the composition to pulsed light comprising broadband spectrum radiation, the pulsed light being at a dose effective to sterilize the composition without causing significant change in rheology of the composition.

Abstract: The present invention is related to a biocompatible and biostable implantable medical device. The present invention can include an implantable medical device including an electro-mechanical component. The electro-mechanical component can be coated with various novel and nonobvious coating combinations designed to promote biocompatibility and biostability. One layer of the coating combinations can be a tie layer. Another layer of the coating combinations can be a layer formed on top of the tie layer, and having biocompatible and biostable properties.

Abstract: An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided.

Abstract: A tissue expander includes an elastomeric shell having an anterior inside surface and a posterior inside surface with a self-healing layer abutting only a portion of the anterior inside surface. The layer is spaced apart from the posterior inside surface while facilitating folding of the shell prior to insertion into a tissue pocket and also enabling inflation of the shell subsequent to insertion by a fluid injected between the self healing layer and posterior surface.

Abstract: A needle guard assembly includes a first composite guard and a second composite guard, each including an arrangement of puncture resistant members on a flexible substrate. The first composite guard and the second composite guard are positioned such that the arrangement of puncture resistant members of the second composite guard are misaligned with the arrangement of puncture resistant members of the first composite guard. The assembly further includes an intermediate layer disposed between and connecting the first composite guard with the second composite guard.

Abstract: An inflatable tissue expander, suitable for implantation in a breast, is provided. In addition, a needle guard assembly, suitable to protect tubing leading from an implantable access port, is provided. The needle guard assembly may include a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are positioned. The needle guard assembly may comprise a sleeve extending over an end of the tube.

Abstract: An inflatable tissue expander, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion.

Abstract: The present invention is related to a biocompatible and biostable implantable medical device. The present invention can include an implantable medical device including an electro-mechanical component. The electro-mechanical component can be coated with various novel and nonobvious coating combinations designed to promote biocompatibility and biostability. One layer of the coating combinations can be a tie layer. Another layer of the coating combinations can be a layer formed on top of the tie layer, and having biocompatible and biostable properties.

Abstract: An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion.

Abstract: The present invention generally provides a gastric banding system, including an implantable access port having a substantially ellipsoid shape. The access port is pliable and smooth, to increase the comfort of the access port to the patient, and to increase the aesthetic effect of the access port. The ellipsoid shape provides a large needle penetrable surface area for the access port, and enhances the ability of a physician to detect the access port through tactile means. A mesh layer may be incorporated in the housing of the access port, to increase durability of the housing, and to promote the self-sealing properties of the housing.